Objective:The aim of this study is to evaluate the effect of foot reflexology on post amputation pain.
Design: A randomized clinical trial
Setting: This study involved two groups of 50 patients undergoing lower limb amputation will be done. Each group consisted of 25 people. Random allocation of samples will be done using block randomization.
Intervention:Foot reflexology will be done for 30 minutes in the intervention group and the control group only foot massage will be done without purpose. Before and after the intervention to assess and compare pain intensity NSR scale is used.
Inclusion criteria: included be conscious, lack of mental retardation, Patient satisfaction in participating in the study.
Exclusion criteria: included lack of patient cooperation during study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016011825929N1
Registration date:2016-02-28, 1394/12/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-28, 1394/12/09
Registrant information
Name
Mehdi Molavi Vardanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3422 5056
Email address
m.molavi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2016-01-30, 1394/11/10
Expected recruitment end date
2016-08-21, 1395/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of foot reflexology on pain of patients after lower limb amputation.
Public title
Effect of foot reflexology on pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Be conscious؛ Lack of mental retardation؛ Patient satisfaction in participating in the study.
Exclusion criteria: Lack of patient cooperation during study.
Age
From 20 years old to 45 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Allocation of samples will be done using block randomization.
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan
City
Isfahan
Postal code
Approval date
2014-11-20, 1393/08/29
Ethics committee reference number
293183
Health conditions studied
1
Description of health condition studied
Injury
ICD-10 code
S88.9
ICD-10 code description
Traumatic amputation of lower leg, level unspecified
Primary outcomes
1
Description
Pain
Timepoint
Before and 30 minutes after intervention
Method of measurement
NSR scale
Secondary outcomes
1
Description
Vital signs
Timepoint
Before and after intervention
Method of measurement
Chek list
Intervention groups
1
Description
In the intervention group, foot reflexology will be performed for thirty minutes. First, the researchers washed their hands with warm water then for thirty minutes to massage the three points of Metatarsus.
Category
Other
2
Description
In the control group only regular foot massage will be performed for thirty minutes.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Mehdi Molavi Vardanjani
Street address
Isfahan- Keshavarz Bolvar
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Isfahan University of Medical Sciences
Full name of responsible person
Mohsen Shahriari
Street address
Isfahan
City
Isfahan
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mehdi Molavi Vardanjani
Position
Master of Sciences
Other areas of specialty/work
Street address
Isfahan
City
Isfahan
Postal code
Phone
+98 31 3775 6084
Fax
Email
m.molavi@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mehdi Molavi Vardanajni
Position
Master of Sciences
Other areas of specialty/work
Street address
Isfahan
City
Isfahan
Postal code
Phone
+98 31 3775 6084
Fax
Email
m.molavi@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of Medical Sciences
Full name of responsible person
Mehdi Molavi Vardanjani
Position
Master of Sciences
Other areas of specialty/work
Street address
Isfahan
City
Isfahan
Postal code
8857113317
Phone
+98 31 3775 6084
Fax
Email
m.molavi@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)